Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

Quality of Life Clinical Trial

— LAPSODY  

Official title:

Assessment of Quality of Life After Low Anterior Resection or Visceral Peritoneal Stripping During cytOreDuctive surgerY for Advanced Ovarian Cancer Requiring Tumor Resection on the Rectosigmoid Colon: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431530
• Other study ID #: LARS-1.0
• Status: Recruiting
• Start date: June 22, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: Soo Jin Park, MD
• Phone: +82-02-2072-2388
• Email: soojin.mdpark[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Description:

In advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. In order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (LAR) is performed to excise the rectum and sigmoid colon. All patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. Therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy.

• Patients with PCDS or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical FIGO stage IIIB or higher

• ECOG performance status : 0-2

• Age over 18

Exclusion Criteria:

• Patient who underwent low anterior resection in the past

• Past history of gastrointestinal malignant tumor except to ovarian cancer

• Patient who have colostomy

• Patient who underwent radiation therapy to abdominal or pelvic cavity

• ECOG performance status over 3

• Patient taking opioid analgesics

• Patient who have intellectual disability or dementia

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Low Anterior Resection Syndrome
• Ovarian Cancer
• Ovarian Neoplasms
• Quality of Life

Intervention

Procedure:
• Cytoreductive surgery
Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (17)

Aletti GD, Dowdy SC, Gostout BS, Jones MB, Stanhope CR, Wilson TO, Podratz KC, Cliby WA. Aggressive surgical effort and improved survival in advanced-stage ovarian cancer. Obstet Gynecol. 2006 Jan;107(1):77-85. doi: 10.1097/01.AOG.0000192407.04428.bb. — View Citation

Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248. — View Citation

Chang SJ, Bristow RE. Evolution of surgical treatment paradigms for advanced-stage ovarian cancer: redefining 'optimal' residual disease. Gynecol Oncol. 2012 May;125(2):483-92. doi: 10.1016/j.ygyno.2012.02.024. Epub 2012 Feb 23. — View Citation

Chen TY, Wiltink LM, Nout RA, Meershoek-Klein Kranenbarg E, Laurberg S, Marijnen CA, van de Velde CJ. Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial. Clin Colorectal Cancer. 2015 Jun;14(2):106-14. doi: 10.1016/j.clcc.2014.12.007. Epub 2014 Dec 31. — View Citation

Ekkarat P, Boonpipattanapong T, Tantiphlachiva K, Sangkhathat S. Factors determining low anterior resection syndrome after rectal cancer resection: A study in Thai patients. Asian J Surg. 2016 Oct;39(4):225-31. doi: 10.1016/j.asjsur.2015.07.003. Epub 2015 Sep 2. — View Citation

Gadan S, Floodeen H, Lindgren R, Matthiessen P. Does a Defunctioning Stoma Impair Anorectal Function After Low Anterior Resection of the Rectum for Cancer? A 12-Year Follow-up of a Randomized Multicenter Trial. Dis Colon Rectum. 2017 Aug;60(8):800-806. doi: 10.1097/DCR.0000000000000818. — View Citation

Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, Holzner B, Kuljanic K, Lebrec J, D'haese S; EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer. 2003 Jul;39(10):1402-8. doi: 10.1016/s0959-8049(03)00307-1. Erratum In: Eur J Cancer. 2003 Nov;39(17):2570. — View Citation

Harpain F, Kranawetter M, Zott T, Lazaridis II, Guenin MO, Ninkovic M, Kronberger IE, Tapiolas I, Basany EE, Dauser B, Herbst F, Koh C, Stift A, Teleky B, Reinthaller A, Grimm C, Riss S. Low anterior resection syndrome (LARS) in ovarian cancer patients - A multi-centre comparative cohort study. Int J Surg. 2020 Jun;78:97-102. doi: 10.1016/j.ijsu.2020.04.019. Epub 2020 Apr 15. — View Citation

Kim CW, Jeong WK, Son GM, Kim IY, Park JW, Jeong SY, Park KJ, Lee SH. Validation of Korean Version of Low Anterior Resection Syndrome Score Questionnaire. Ann Coloproctol. 2020 Apr;36(2):83-87. doi: 10.3393/ac.2019.08.01. Epub 2020 Feb 11. — View Citation

Kim MJ, Park JW, Lee MA, Lim HK, Kwon YH, Ryoo SB, Park KJ, Jeong SY. Two dominant patterns of low anterior resection syndrome and their effects on patients' quality of life. Sci Rep. 2021 Feb 11;11(1):3538. doi: 10.1038/s41598-021-82149-9. — View Citation

Kranawetter M, Ataseven B, Grimm C, Schneider S, Riss S, Alesina P, Prader S, Walz MK, Harpain F, Stift A, Heitz F, Reinthaller A, Polterauer S, Harter P, du Bois A. Low anterior resection syndrome (LARS) in patients with epithelial ovarian cancer after primary debulking surgery. Gynecol Oncol. 2019 Sep;154(3):577-582. doi: 10.1016/j.ygyno.2019.06.015. Epub 2019 Jun 21. — View Citation

Park SJ, Mun J, Lee EJ, Park S, Kim SY, Lim W, Song G, Kim JW, Lee S, Kim HS. Clinical Phenotypes of Tumors Invading the Rectosigmoid Colon Affecting the Extent of Debulking Surgery and Survival in Advanced Ovarian Cancer. Front Oncol. 2021 Apr 22;11:673631. doi: 10.3389/fonc.2021.673631. eCollection 2021. — View Citation

Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236. — View Citation

Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum. 1999 Dec;42(12):1525-32. doi: 10.1007/BF02236199. — View Citation

Shimada M, Kigawa J, Minagawa Y, Irie T, Takahashi M, Terakawa N. Significance of cytoreductive surgery including bowel resection for patients with advanced ovarian cancer. Am J Clin Oncol. 1999 Oct;22(5):481-4. doi: 10.1097/00000421-199910000-00012. — View Citation

Son JH, Kim J, Shim J, Kong TW, Paek J, Chang SJ, Ryu HS. Comparison of posterior rectal dissection techniques during rectosigmoid colon resection as part of cytoreductive surgery in patients with epithelial ovarian cancer: Close rectal dissection versus total mesorectal excision. Gynecol Oncol. 2019 May;153(2):362-367. doi: 10.1016/j.ygyno.2019.02.029. Epub 2019 Mar 4. — View Citation

Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. doi: 10.1023/B:QURE.0000021692.81214.70. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of major LARS after surgery	Frequency of major LARS (corresponding to 30-42 points as a result of LARS questionnaire) 12 months after LAR implementation	12 months after LAR implementation
Secondary	Incidence of major, minor LARS after visceral peritoneal stripping	Incidence of major, minor LARS after visceral peritoneal stripping, not LAR	2weeks after surgery
Secondary	LARS severity	LARS severity of before and after surgery(before adjuvant chemotherapy)	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
Secondary	The fecal incontinency quality of life scale(FIQL)	FIQL of before and after surgery	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
Secondary	Bristol stool form scale	Bristol stool form scale of before and after surgery	2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery
Secondary	EORTC QLQ-Ov28	EORTC QLQ-Ov28 of before and after surgery	2weeks before surgery, 6,12,24 months after surgery
Secondary	EOTC QLQ-C30	EOTC QLQ-C30 of before and after surgery	2weeks before surgery, 6,12,24 months after surgery